Juparib 150 mg (Tablet)

Indications

• Breast Cancer treatment
• Ovarian Cancer maintenance treatment
• Treatment for patients with deleterious germline BRCA-mutated metastatic breast cancer
• Treatment for patients with hormone receptor-positive breast cancer
• Platinum sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer treatment

Pharmacology

• Inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes
• Inhibition of growth of select tumor cell lines
• Decrease in tumor growth in mouse xenograft models
• Increased cytotoxicity and anti-tumor activity in deficient BRCA cell lines
• Rapid absorption following oral administration
• Limited accumulation with steady state exposures achieved within 3-4 days

Dosage & Administration

• Recommended dose of 400 mg taken orally twice daily
• Take with or without food
• Consider dose modification for adverse reactions
• Dose reduction for use with CYP3A inhibitors
• No adjustment required for patients with mild renal impairment

Interaction

• Potentiation and prolongation of myelosuppressive toxicity with anticancer agents
• Drugs that may increase plasma concentrations
• Drugs that may decrease plasma concentrations
• Avoid concomitant use of strong and moderate CYP3A inhibitors
• Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during treatment

Contraindications

• Hypersensitivity to the drug or any ingredient in the formulation

Side Effects

• Common serious adverse reactions: anemia, dermatitis allergic, neutrophil count decreased, platelet count decreased
• Proportion of patients permanently discontinuing due to adverse events
• Adverse reactions leading to discontinuation: anemia, platelet count decrease

Pregnancy & Lactation

• Potential fetal harm
• Potential risk for loss of the pregnancy
• Unknown excretion in human milk

Precautions & Warnings

• Incidence of Myelodysplastic Syndrome/Acute Myeloid Leukemia in patients treated with the drug
• Pneumonitis occurrence in patients treated with the drug

Overdose Effects

• No specific treatment established
• General supportive measures and symptomatic treatment recommended

Therapeutic Class

• Targeted Cancer Therapy

Storage Conditions

• Store in a dry place below 30°C
• Protect from light
• Keep out of the reach of children

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